title: A randomized, double-blind, placebo-controlled study of fentanyl buccal tablets for breakthrough pain: efficacy and safety in Japanese cancer patients.
abstract: BACKGROUND
  Rapid-onset opioids for treating breakthrough pain (BTP) in patients with cancer are needed in the Japanese care setting.
  
  
  OBJECTIVE
  To examine the efficacy and safety of fentanyl buccal tablets (FBTs) for treating BTP in Japanese cancer patients.
  
  
  METHODS
  This was a randomized, double-blinded, placebo-controlled study. In subjects receiving around-the-clock (ATC) opioids at doses of 30 mg or more to less than 60 mg or 60-1000 mg of oral morphine equivalents (low and high ATC groups), dose titration was started from 50 to 100 μg FBT, respectively. Subjects whose effective dose was identified were randomly allocated to a prearranged administration order of nine tablets (six FBTs and three placebos), one tablet each for nine episodes of BTP (double blinded). Efficacy and safety of FBT were assessed for patients overall, and also for the low and high ATC groups.
  
  
  RESULTS
  A significant difference was observed between FBT and placebo for the primary endpoint of pain intensity difference at 30 minutes. The analgesic onset of FBT was observed from 15 minutes in several secondary variables (e.g., pain relief). Adverse events were somnolence and other events associated with opioids were mostly mild or moderate. Of the low and high ATC group subjects, an effective FBT dose was identified in 72.2% and 73.1%, respectively.
  
  
  CONCLUSIONS
  The safety of FBT and its analgesic effect on BTP were confirmed in Japanese cancer patients receiving opioids. Our findings suggest that analgesic onset may occur from 15 minutes after FBT, and that FBT can be administered to patients with low doses of ATC opioids.
authors.affiliation: Department of Palliative Care, Saga-Ken Medical Center Koseikan, Saga, Japan. Electronic address: kosugi0416@gmail.com.
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Kosugi
authors.affiliation: Department of Palliative Care, Saga-Ken Medical Center Koseikan, Saga, Japan.
authors.forename: Sasagu
authors.initials: S
authors.lastname: Hamada
authors.affiliation: Department of Palliative Medicine, KKR Sapporo Medical Center, Sapporo, Japan.
authors.forename: Chizuko
authors.initials: C
authors.lastname: Takigawa
authors.affiliation: Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan.
authors.forename: Katsunori
authors.initials: K
authors.lastname: Shinozaki
authors.affiliation: Department of Palliative Medicine, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kunikane
authors.affiliation: International University of Health and Welfare Hospital, Tokyo, Japan.
authors.forename: Fumio
authors.initials: F
authors.lastname: Goto
authors.affiliation: Department of Medical Oncology, Tohoku Rosai Hospital, Sendai, Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Tanda
authors.affiliation: Department of Palliative Medicine, Tsukuba Medical Center Hospital, Tsukuba, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Shima
authors.affiliation: Department of Palliative Care, Saitama Cancer Center, Saitama, Japan.
authors.forename: Kinomi
authors.initials: K
authors.lastname: Yomiya
authors.affiliation: Department of Palliative Medicine, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Motohiro
authors.initials: M
authors.lastname: Matoba
authors.affiliation: Division of Palliative Medicine, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Isamu
authors.initials: I
authors.lastname: Adachi
authors.affiliation: Department of Palliative and Supportive Care, Social Insurance Chukyo Hospital, Nagoya, Japan.
authors.forename: Tetsusuke
authors.initials: T
authors.lastname: Yoshimoto
authors.affiliation: Department of Internal Medicine and Medical Oncology, Teikyo University School of Medicine, Tokyo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Eguchi
mesh_terms: D000278:Administration, Buccal; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D059390:Breakthrough Pain / Q000188:drug therapy* / Q000503:physiopathology*; D004311:Double-Blind Method; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000503:physiopathology*; D059408:Pain Management / Q000379:methods; D010147:Pain Measurement; D010166:Palliative Care / Q000379:methods; D012119:Respiration / Q000187:drug effects; D013607:Tablets; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D013607:Tablets; D005283:Fentanyl
keywords: Fentanyl buccal tablet; breakthrough pain; cancer pain; oral transmucosal opioid; palliative medicine; rapid-onset opioids